Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Institut Gustave Roussy.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Institut Gustave Roussy

ClinicalTrials.gov Identifier:

NCT00180986

First received: September 13, 2005

Last updated: December 13, 2005

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 13, 2005

Start Date ^ICMJE

October 1995

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00180986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

Official Title ^ICMJE

Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

Brief Summary

Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)

Intervention ^ICMJE

Procedure: Platelet concentrates

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

120

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
Written informed consent was required from parents of eligible children.

Exclusion Criteria:

Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.

Gender

Both

Ages

up to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00180986

Other Study ID Numbers ^ICMJE

Minnie, CSET 94/357

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Institut Gustave Roussy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Valérie LAPIERRE, MD

Institut Gustave Roussy

Information Provided By

Institut Gustave Roussy

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top